Clinical Trial to Assess the Effectiveness of I+Med's DayDrop Advanced Ophthalmic Drop

i+Med S.Coop.45 enrolled

Overview

Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Follow-up will be 12 weeks with a maximum of 4 visits.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye Syndrome

Interventions

DayDrop Advanced ophthalmic dropDEVICE

The patient will administer 1 or 2 drops of DayDrop Advanced in each eye 3 times a day for 3 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of both sexes over 18 years of age. * Patients diagnosed with mild-moderate dry eye who meet the following characteristics: Schirmer test ≥3 and ≤ 10 mm; BUT test ≥5 and ≤ 10 seconds and OSDI ≥13 and ≤ 33. * Patients without other ophthalmologic pathologies. * Have ability to self-administer drops. * Have ability to understand the Patient Information Sheet. * Sign the Informed Consent. Exclusion Criteria: * Patients diagnosed with severe dry eye. * Ingestion of parasympathomimetic or antipsychotic medications . * Glaucoma. * Previous cataract surgery. * Systemic treatment with corticosteroids or topical treatment with any ophthalmic medication except artificial tears in the week prior to the start of study treatment. * Ocular infection or clinically significant inflammation. * Ocular surgery in the 3 months prior to the study. * Sjögren's syndrome. * Stevens-Johnson syndrome. * History of allergic conjunctivitis. * Pregnancy or planned lactation.

Locations (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, Spain

Outcomes

Primary Outcomes

Changes in the intensity of dry eye measured by Schirmer's test.

The Schirmer test measures the amount of tears produced in mm of wetted strip.A greater distance in the Schirmer test implies a higher amount of tears produced and therefore a lower intensity of dry eye.

Time frame: At baseline, in week 4 and in week 12

Secondary Outcomes

Changes in dry eye signs through modifications in tear film thickness measured by Optical Coherence Tomography.

Optical Coherence Tomography (OCT) evaluates changes in dry eye signs through changes in the thickness of the tear film, measured in microns.

Time frame: At baseline, in week 4 and in week 12

Changes in dry eye signs through the tear breakup time measured by TBUT test.

The TBUT test measures the tear break-up time (seconds until the appearance of tear break-up). Normal values are considered to be 10 seconds or more. The values from both eyes will be collected, and an average will be calculated for analysis.

Time frame: At baseline, in week 4 and in week 12

Changes in dry eye symptoms through the OSDI scale.

The OSDI scale allows for the assessment of the severity and classification of dry eye. The test results are classified as ≤13 normal, between 13 and 22 mild/moderate, and between 23 and 50 moderate/severe.

Time frame: At baseline, in week 4 and in week 12

Satisfaction with Treatment.

Pacient´s satisfaction with the treament as assessed using a brie survey. Possible responses range from not satisfied, indifferent, satisfied, very satisfied, and exceptionally satisfied.

Time frame: At Week 12

Adverse events.

Evaluating number and severity of adverse events.

Data from ClinicalTrials.gov

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